Williams v. Nidek Co., Ltd.

Full title: KATHLEEN WILLIAMS et al., Plaintiffs and Appellants, v. NIDEK CO., LTD. et…

Court: California Court of Appeals, Fourth District, First Division

Date published: Feb 2, 2009

No. D050753 (Cal. Ct. App. Feb. 2, 2009)

Opinion

KATHLEEN WILLIAMS et al., Plaintiffs and Appellants, v. NIDEK CO., LTD. et al., Defendants and Respondents. D050753 California Court of Appeal, Fourth District, First Division February 2, 2009

NOT TO BE PUBLISHED IN OFFICIAL REPORTS

APPEAL from an order of the Superior Court of San Diego County Super. Ct. No. GIC842089, Steven R. Denton, Judge.

McDONALD, J.

Plaintiffs Kathleen Williams and Ronald Marmo (together plaintiffs) underwent Lasik and/or PRK refractive eye surgery involving hyperopic corrections. The procedures were performed by Doctor Glenn Kawesch (Kawesch) using the EC-5000 Excimer Laser System (Laser), at a time when the Laser, although approved by the federal Food and Drug Administration (FDA) for treatment of myopia, had not yet been approved for hyperopic corrections. Plaintiffs subsequently filed this action against Kawesch and named, as additional defendants, Nidek Incorporated (Nidek) (whose parent company is Nidek Co., Ltd.), the distributor of the Laser, and two other named physician defendants (defendants John Kownacki and Steven Ma) who purchased and used the Laser to perform LASIK and/or PRK procedures on patients. The gravamen of plaintiffs' action alleged the named physician defendants, and numerous other physicians throughout the country named as Doe defendants, had used the Laser to perform hyperopic corrections on patients while concealing that the Laser had only been approved by the FDA for myopic corrections. Plaintiffs alleged Nidek was liable because its actions enabled the physicians to use the Laser to conduct the nonapproved procedures.

Plaintiffs' second amended complaint (SAC), styled as a proposed class action lawsuit, alleged 11 causes of action. Nine of the claims (the common claims) were directed at all defendants, including Nidek. Four of the common claims (the first through fourth causes of action) alleged the various activities of all defendants violated California's Unfair Competition Law (Bus. & Prof. Code, § 17200 et seq. (UCL)), one of the common claims (the fifth cause of action) alleged the activities of all defendants violated California's False and Misleading Advertising Act (Bus. & Prof. Code, § 17500 et seq. (FMAA)), and one of the common claims (the sixth cause of action) alleged the activities of the defendants violated California's Consumer Legal Remedies Act (Civ. Code, § 1750 et seq. (CLRA)). The remaining common claims were common law causes of action for intentional misrepresentation by concealment (the seventh cause of action), conspiracy (the eighth cause of action), and negligence (the 11th cause of action). The SAC also alleged, against both the named and Doe physician defendants but not against Nidek, causes of action for medical malpractice and negligence per se (the ninth and 10th causes of action).

The present appeal purports to challenge two orders entered by the trial court. First, plaintiffs assert the trial court erred when it denied their motion for class certification. Because that ruling is properly before us, we address this issue on the merits. Plaintiffs' second challenge purports to attack the court's entry of summary adjudication in favor of Nidek on the first through fifth causes of action (the summary adjudication order). Nidek has moved to dismiss the appeal of this order, arguing plaintiffs improperly seek to challenge by appeal a matter that may only be raised by a timely writ proceeding. Because we agree plaintiffs may not raise these issues by appeal, and therefore grant Nidek's motion to dismiss plaintiffs' appeal insofar as it purports to appeal from the summary adjudication order in favor of Nidek, we do not reach the merits of the ruling on the summary adjudication motion.

I

THE SUMMARY ADJUDICATION ORDER

A. Procedural Background

Nidek moved for summary adjudication on plaintiffs' UCL/FMAA claims (the first through fifth causes of action), arguing plaintiffs were unable to show either a right to restitution from or injunctive relief against Nidek. The trial court ruled that, as a matter of law, plaintiffs' UCL/FMAA claims could not be maintained against Nidek, and granted Nidek's summary adjudication motion on the first through fifth causes of action. Plaintiffs did not file a writ petition with this court as authorized by Code of Civil Procedure¹ section 437c, subdivision (m).

1 All further statutory references are to the Code of Civil Procedure unless otherwise specified.

After the court denied plaintiffs' motion for class certification, and denied plaintiffs' motion for reconsideration of the class certification motion, plaintiffs filed a notice of appeal challenging the order denying class certification. Plaintiffs' notice of appeal also purported to appeal the summary adjudication order in favor of Nidek. Nidek has moved to dismiss the appeal of the summary adjudication order, which dismissal plaintiffs oppose, and this court ordered Nidek's motion to dismiss be considered concurrently with the appeal.

B. Analysis

Nidek argues, and plaintiffs concede, an order granting summary adjudication is ordinarily not an appealable order. (See, e.g., Fisherman's Wharf Bay Cruise Corp. v. Superior Court (2003) 114 Cal.App.4th 309, 319.) An order granting summary adjudication remains nonappealable even where the ruling severely truncates the case and leaves only a small portion open to future resolution. (Hoveida v. Scripps Health (2005) 125 Cal.App.4th 1466, 1468-1469.) A party aggrieved by an order granting summary adjudication must either (1) seek review of the order by a timely writ petition (Fisherman's Wharf, supra) or (2) await the final judgment disposing of all the issues between the parties and seek review of the summary adjudication order on appeal from the final judgment. (Hoveida v. Scripps Health, supra.)

Plaintiffs did not file a petition for writ of mandamus within the jurisdictional period (Sturm, Ruger & Co. v. Superior Court (1985) 164 Cal.App.3d 579, 581-582), and instead purport to appeal from the summary adjudication order. Because we do not have jurisdiction to consider the issues involved in the summary adjudication order (Hoveida v. Scripps Health, supra, 125 Cal.App.4th 1466), the proper disposition of that aspect of the appeal is to dismiss the appeal as to the nonappealable order and limit review to the appealable order. (Ibid; see also Walker v. v. Los Angeles County Metropolitan Transportation Authority (2005) 35 Cal.4th 15, 20 [" 'When a party appeals from both appealable and nonappealable orders, courts in this state regularly dismiss the appeal from the latter order' . . . [and proceed] . . . to consider the appeal based on the other, properly filed notice of appeal from the judgment."].)

Plaintiffs argue, without citation to relevant authority, an exception to the nonappealability rule exists in this case because the denial of the class certification order disposed of all causes of action assertable by the class. From this predicate, plaintiffs assert the appeal from the order denying certification, which is an appealable order (Linder v. Thrifty Oil Co. (2000) 23 Cal.4th 429, 435 (Linder)), is an appeal from a final judgment and may encompass all issues relating to the class that are final, including the summary adjudication order. However, the fact the order denying the motion to certify the class is appealable does not necessarily mean all prior nonappealable rulings entered against the individual plaintiffs are converted into appealable orders. To the contrary, logic dictates nonappealable orders entered against the individual plaintiffs (as was the summary adjudication order here) are not transmogrified into appealable orders merely because the individual plaintiffs may appeal the limited question of whether they should have been permitted also to pursue the action on behalf of similarly situated persons. If the plaintiffs were to prevail on appeal as to the class certification order, the newly created class would have no greater rights than plaintiffs (as their class representatives) possess individually, and plaintiffs do not dispute that they do not (in their individual capacities) have the right to pursue an appeal from the summary adjudication order. Conversely, if plaintiffs do not prevail on appeal as to the class certification order, there would be no final disposition of any claims held by unrepresented class members from which an appeal might lie.² (See generally Ortiz v. Lyon Management Group, Inc. (2007) 157 Cal.App.4th 604, 623-625 [merits rulings as to individual plaintiffs bind only individual plaintiffs and do not bind absent members of an uncertified class].)

2 Because we affirm the order denying certification, we cannot perceive how there can be any person with standing to pursue the appeal on behalf of the class: (1) the named plaintiffs will have been denied the right to pursue claims on behalf of the unnamed members of the proposed but rejected class; and (2) no unnamed member of the proposed but rejected class would be aggrieved by the summary adjudication order, an essential requirement for standing to pursue an appeal. (See generally 9 Witkin, Cal. Procedure (5th ed. 2008) Appeal, §§ 33 et seq., p. 94 et seq.)

C. Conclusion

We conclude, insofar as plaintiffs purport to appeal the summary adjudication order, that aspect of the appeal must be dismissed, and we instead must limit appellate review to only those orders from which the appeal was properly taken.³ (Martin v. Johnson (1979) 88 Cal.App.3d 595, 608.) Because the order denying plaintiffs' motion for class certification is an appealable order, we limit our review to that order.

3 Because we conclude the summary adjudication order is not appealable, the bulk of the arguments raised by the Attorney General in his amicus brief are moot. The Attorney General's amicus brief does not focus on the propriety of the order denying class certification, but instead argues the restitutionary remedies available under the UCL and FMAA are available against Nidek without the necessity of tracing funds from the class members to Nidek. Because the summary adjudication order (based primarily on the tracing issue) is not properly before us, we do not address the tracing arguments raised by the Attorney General.

II

LAW APPLICABLE TO CLASS CERTIFICATION ORDER

A. Standards for Class Actions

Section 382 authorizes class actions in California when "the question is one of a common or general interest, of many persons, or when the parties are numerous, and it is impracticable to bring them all before the court." The burden is on the party seeking certification to establish the existence of both an ascertainable class and a well-defined community of interest among the class members. (Linder, supra, 23 Cal.4th at p. 435.) To establish the requisite community of interest, the proponent of certification must show there are questions of law or fact common to the proposed class (the commonality criteria), and those questions predominate over the different questions affecting individual members (the predominance criteria). (See Richmond v. Dart Industries, Inc. (1981) 29 Cal.3d 462, 470.) The community of interest requirement also requires a showing that the proposed class representatives have claims or defenses typical of those held by the class and can adequately represent the class. (Lockheed Martin Corp. v. Superior Court (2003) 29 Cal.4th 1096, 1104.)

The predominance criteria means "each member must not be required to individually litigate numerous and substantial questions to determine his [or her] right to recover following the class judgment; and the issues which may be jointly tried, when compared with those requiring separate adjudication, must be sufficiently numerous and substantial to make the class action advantageous to the judicial process and to the litigants." (City of San Jose v. Superior Court (1974) 12 Cal.3d 447, 460.) When the proposed class action will not provide substantial benefits both to the courts and the litigants, it is proper to deny certification. (Linder, supra, 23 Cal.4th at p. 435.)

In addition to showing predominance of common questions, the proponent has the burden to show the proposed class is ascertainable. "Whether a class is ascertainable is determined by examining (1) the class definition, (2) the size of the class, and (3) the means available for identifying class members. [Citations.]" (Reyes v. Board of Supervisors (1987) 196 Cal.App.3d 1263, 1271.) Ascertainability, a separate criterion required "to give notice to putative class members as to whom the judgment in the action will be res judicata" (Hicks v. Kaufman & Broad Home Corp. (2001) 89 Cal.App.4th 908, 914), is best implemented by "defining the class in terms of objective characteristics and common transactional facts making the ultimate identification of class members possible when that identification becomes necessary." (Id. at p. 915.) The ascertainability of members of the class recedes as the right of each individual to recover becomes increasingly dependent on a separate set of facts applicable only to the individual. (Cf. Vasquez v. Superior Court (1971) 4 Cal.3d 800, 809.)

A proponent at the class certification stage is not required to identify individual class members (Stephens v. Montgomery Ward (1987) 193 Cal.App.3d 411, 419), demonstrate the merits of their claims (Linder, supra, 23 Cal.4th at p. 440), show that each class member has been injured (Hicks v. Kaufman & Broad Home Corp., supra, 89 Cal.App.4th at p. 914), or identify a form of notice (Linder, at p. 444), to obtain certification. However, the trial court is entitled to consider "the totality of the evidence in making [the] determination" of whether a "plaintiff has presented substantial evidence of the class action requisites" (Quacchia v. DaimlerChrysler Corp. (2004) 122 Cal.App.4th 1442, 1448 (Quacchia)), including whether the causes of action asserted on behalf of the proposed class would involve the resolution of common issues of fact and law that predominate over the factual and legal issues applicable to the individual class members' right to recover on those causes of action. (Id. at pp. 1449-1454.)

B. Standard of Appellate Review

"Because trial courts are ideally situated to evaluate the efficiencies and practicalities of permitting group action, they are afforded great discretion in granting or denying certification" (Linder, supra, 23 Cal.4th at p. 435), and " '[a]ny valid pertinent reason stated will be sufficient to uphold the order' " (id. at p. 436), as long as the stated reasons are supported by the evidence (cf. Sav-On Drug Stores, Inc. v. Superior Court (2004) 34 Cal.4th 319, 328) or by any properly implied findings. (Massachusetts Mutual Life Ins. Co. v. Superior Court (2002) 97 Cal.App.4th 1282, 1287-1288.)

However, "an order based upon improper criteria or incorrect assumptions calls for reversal ' "even though there may be substantial evidence to support the court's order." ' " (Linder, supra, 23 Cal.4th at p. 436.) Accordingly, we may examine the stated reasons for the order to determine whether the court relied on improper criteria to deny certification. (Ibid.)

III

PROCEDURAL AND FACTUAL BACKGROUND RELEVANT TO CLASS CERTIFICATION ORDER

A. Allegations of Plaintiffs' SAC

Plaintiffs' SAC alleged four claims under the UCL (the first through fourth causes of action), and a fifth claim under the FMAA (the fifth cause of action). These claims alleged the named and Doe physician defendants⁴ were liable under those statutes for profiting from unlawful business practices because, although the FDA's pre-market approval (PMA) for the Laser only permitted its use for myopia (and later for myopia with astigmatism), the physicians unlawfully used the Laser to perform procedures to correct hyperopic conditions.

4 Our evaluation of the propriety of the ruling on the certification motion, insofar as plaintiffs argue it was error to deny certification of a class as to their first five causes of action, focuses principally on the facts applicable to the named and Doe physicians because (as previously discussed) Nidek obtained summary adjudication in its favor as to plaintiffs' first five claims.

The SAC alleged the physicians violated the UCL because their unapproved use of the Laser constituted (1) use of an "adulterated" device in violation of title 21 United States Code section 331 (first cause of action), (2) use of a "misbranded" device in violation of title 21 United States Code section 331 (second cause of action), (3) a violation of the recertification and reidentification standards under 21 Code of Federal Regulations part 1040.10 (third cause of action), and (4) a violation of Health and Safety Code section 111440 et seq. for selling misbranded devices (fourth cause of action). The SAC alleged the physician defendants violated the FMAA because such unapproved use constituted a false or misleading representation to class members that the Lasers were appropriate or approved for hyperopic procedures (the fifth cause of action).

The SAC also alleged the activities of the defendants violated the CLRA (the sixth cause of action), and committed common law fraud (seventh cause of action), because they misrepresented the quality and safety of the Lasers to the public, and damaged the public, by using it for purposes for which it did not have FDA approval without revealing to patients that the Laser (1) was "adulterated" or "misbranded" and (2) was not approved for hyperopic procedures. The SAC also alleged all defendants engaged in a conspiracy to (1) misrepresent the safety of the Laser for hyperopic procedures, (2) withhold from the public the fact that use of the Laser for hyperopic procedures was unlawful, and (3) continue using the Laser to treat members of the class for hyperopic corrections. The SAC also alleged (as to all defendants) a common law negligence claim (the 11th cause of action), alleging all defendants owed a duty of care to give notice to prospective patients that the Laser was not approved for hyperopic corrections and to prevent the Laser from being used for unapproved procedures, they breached this duty, and the breach proximately caused economic and personal injury to class members.

The SAC also alleged, solely against the named and Doe physician defendants, causes of action for medical malpractice and negligence per se (the ninth and 10th causes of action). The complaint alleged that as a result of the malpractice and/or the violation of statutes designed to protect the patients, plaintiffs and class members suffered damages, in the form of physical injuries and economic losses, for which the physician defendants were liable.

B. Factual Showing Relevant to Class Certification Motion ⁵

5 We limit our factual recitation to the facts before the court when it ruled on the class certification motion and, for the reasons discussed below (see section V, post), do not evaluate the court's ruling based on facts subsequently introduced by plaintiffs when they moved for reconsideration of the denial of class certification.

Nidek

Nidek distributed the Laser, a Class III medical device, manufactured by its parent company, Nidek Co., Ltd. The Laser obtained its first PMA in late 1998 and, by April 2000, had received PMA's from the FDA for Lasik procedures for treatment of myopia and myopia with astigmatism within certain limitations. However, Nidek's application to the FDA for use of the Laser to treat hyperopia was not approved until 2006. The FDA-approved software for conducting the approved treatments was included in Lasers sold in the United States, and the FDA-approved promotional material and operating manual accompanying the Laser clearly advised physicians the FDA had approved the Laser for certain uses that did not include treatment for hyperopia.

In 1999 rumors were circulating in the ophthalmology community that a software chip was available in Canada that, when installed on the Laser, would enable the Laser also to be used for hyperopic corrections.⁶ In 1999, Nidek began learning (from reports of some of its service representatives) some Lasers had been modified with the unapproved software that enabled the Laser to treat hyperopia. Nidek immediately implemented a policy that required its service technicians to report any unapproved software discovered during service calls and, when unapproved software was detected, generated a "dear doctor" letter for the owners of those Lasers informing the physicians of the approved uses of the Laser and asking the doctors to confirm (1) they were not using unauthorized software, (2) they were or would be involved in an appropriate clinical study, or (3) they were using unauthorized software and agreed to having Nidek technicians restore the software on the Laser to the approved configuration.

6 Plaintiffs cite no evidence in the record suggesting the unapproved software was manufactured by Nidek, and the record suggests the chips may have been cloned (or reverse engineered and copied) from Nidek-manufactured chips.

Nidek took subsequent steps to create and implement a software and hardware block on the Lasers to prevent them from being used for unapproved procedures, and to implement a program to contact existing users to request permission to have service technicians conduct service calls to install the block on the Lasers. Nidek kept the FDA apprised of its efforts, and by mid-2002, Nidek reported to the FDA there were 36 remaining sites where a block had not yet been performed. Seven of those sites were scheduled for installation of the block, but two had closed and 27 had either not responded to Nidek's request or had declined to allow Nidek to install the block.

Kawesch and Kownacki

Kawesch purchased his Laser in late 1998. It was equipped with the international version of the software, designated as "2.25cHC," which allowed the Laser to be used to treat myopia, myopia with astigmatism, and hyperopia.⁷ However, in January 1999, when technicians upgraded its software to install version "2.25dHC," which similarly permitted the Laser to be used to treat myopia, myopia with astigmatism, and hyperopia, the technicians removed the "hyperopic" menu. Kawesch was one of the physicians to whom Nidek sent the "dear doctor" letter, seeking access to install the hardware and software block on the Laser, but Kawesch stated he was not using the Laser for unapproved applications and that a site visit was therefore unnecessary. Nidek's reports to the FDA identified Kawesch's office as one of the sites that would not make the Laser available for installation of the block, although Nidek was finally able to obtain permission and installed the block in December 2001.

7 Before agreeing to sell Kawesch the Laser with software allowing these treatments, Nidek confirmed he was enrolled in an approved clinical study allowing Kawesch to perform procedures under a clinical protocol to treat myopia with astigmatism. When Kawesch enrolled in the study, he agreed not to use the Laser for any purpose other than myopic treatments. Kawesch was dropped from the study in July 2000, and Nidek was informed of this in August 2000. Nidek subsequently sent a "dear doctor" letter to Kawesch, apparently as part of the program responding to FDA concerns over unapproved software that enabled the Laser to be used for hyperopic corrections. Kawesch responded that the Laser did not include any adjustments or alterations that would permit "off-label" procedures and Kawesch was not performing and did not intend to perform any off-label procedures.

Kawesch's patients, including plaintiffs, received and signed informed consent forms prior to their procedures. The forms explained Kawesch employed off-label uses of the Laser, specifically identified treatment for hyperopia as an off-label use of the Laser, and confirmed the patient (1) had discussed the risks and benefits of this off-label treatment with Kawesch or his staff; (2) understood the risks, benefits and alternatives; and (3) agreed to the procedure.⁸ Kownacki practiced with Kawesch during the time the unapproved software was active on Kawesch's Laser, and Kownacki's name appears on the informed consent form signed by plaintiffs. Plaintiffs conceded they did not rely on any representation by Kawesch regarding the FDA-approval of the Laser when they agreed to the surgery, and do not contend they were disappointed in the results of the surgery.

8 The consent form used by Kawesch, and signed by his patients (including plaintiffs), stated:

Ma

Doctor Ma acquired his Laser in late 1999. It was not equipped with the software that would allow the Laser to be used to treat hyperopia, but instead was equipped only with the software (version 2.25c) approved by the FDA. However, in May 2000, a Nidek service representative noted the presence of the unapproved software (version 2.25eHC), and Nidek sent Ma a "dear doctor" letter.⁹ Ma returned the letter, indicating the Laser "has been modified but we will be submitting a physician-sponsored Investigational Device Exemption (IDE) application to the [FDA] in the near future concerning our use of the [Laser] for any off[-]label uses." Ma ultimately permitted Nidek to install the software block on his Laser in September 2002.¹⁰

9 Ma obtained the unapproved software from a person in Canada (who may have claimed to have been a Nidek technician) and Ma had it installed during a service visit. Ma also stated that, after the block was installed, he was unable to use the Laser for hyperopia for two years. However, in late 2004, he obtained other software to again allow hyperopic enhancements and asked a Nidek technician to install the new software "on [the technician's] own time." The new software allowed him to perform hyperopic enhancements until it was removed in 2006.

10 However, there was some evidence that, after Nidek installed the blocking software on Ma's Laser, Ma was able to reinstall software on his Laser that permitted him to perform hyperopic enhancements for some period.

Ma explained that, when discussing procedures for hyperopic corrections with his patients, he discussed off-label uses and offered two options to his patients: they could elect to undergo surgery at USC Doheny Eye Institute with a laser approved by the FDA for treatment of hyperopia, or they could elect to have treatment in his office using the Laser. He told his patients that use of the Laser for hyperopia was "something that I've done before in Canada, but in the U.S., currently, it's not approved on this laser. But doing it on the Doheny Laser, the hyperopia would be approved." He also testified that approximately one-third of the hyperopic procedures using the Laser were performed on "virgin eyes" (eyes undergoing surgery for the first time) and the balance were "enhancements" (additional procedures on previously treated eyes designed to improve visual acuity). He advised his patients it would cost $1500 to treat two virgin eyes for hyperopia with the Laser, but he would have to charge $3500 for the same treatment using the Doheny laser.¹¹

11 Ma also explained most of the "hyperopia" procedures he performed were corrections (or enhancements), for which he did not charge, that arose when the original virgin eye procedure was to treat myopia but the procedure overcorrected the myopia condition and he therefore utilized the hyperopic functions to adjust for the overcorrection. He also explained he sometimes used the hyperopic software in conjunction with treating myopia with an astigmatism to create a smoother blend of the cornea.

C. The Class Certification Motion

Plaintiffs moved to certify two classes (a nationwide class and a California class) as to all claims for all nonpersonal injury damages alleged by plaintiffs (including economic damages and punitive damages for the fraudulent conduct of the named and Doe defendants), and proposed to define each class to include all persons " 'who had hyperopic laser surgery performed using a [Laser] who were not enrolled in a clinical trial.' " Plaintiffs' counsel estimated, in addition to the named physicians and Nidek, there were 60 to 70 doctors nationally and 17 doctors in California against whom the class action would proceed. Plaintiffs asserted all elements necessary to certification were present because (1) the class was large and was ascertainable, (2) there was a well-defined community of interest among the class members because there were common questions of law or fact to the proposed class that predominated over the questions affecting individual members, and (3) the proposed class representatives had claims or defenses typical of those held by the class and could adequately represent the class. On the commonality issue, plaintiffs argued all class members (1) had been subjected to treatment with an unapproved Laser without being informed of its unapproved status and instead defendants had concealed that information, (2) would not have undergone treatment had they been aware of the true facts, and (3) as a result had suffered economic damages because they did not receive the benefit of their bargain.

All defendants opposed the motion to certify the class. In addition to raising substantial other obstacles to class certification,¹² the defendants argued individualized questions as to each class member would predominate over the common questions applicable to the class. The defendants first noted the core of plaintiffs' CLRA and common law fraud, conspiracy and negligence claims (as well as the crux of a significant portion of plaintiffs' UCL/FMAA claims for misbranding and false advertising) revolved around the allegation that the physicians falsely represented to patients the Laser's FDA approval status (or alternatively concealed its nonapproved status) to induce the patient to consent to and pay for the surgery. Defendants argued the "representation/concealment" issue would require a plethora of particularized inquiries that would initially splinter the class because this issue would require thousands of mini-trials on what representations were made to, and relied on by, individual class members.¹³ Indeed, because and to the extent that plaintiffs' proposed class action sought recovery for economic damages measured under a "benefit of the bargain" theory¹⁴ (seeking recovery of the difference between the value of what was promised and what was received), it would be essential that each class member establish what was promised. Moreover, noted Nidek, because a significant subsidiary issue raised by plaintiffs' "representation/concealment" allegations involved potential statute of limitations/tolling questions for a substantial number of proposed class members, postsurgery issues and attendant physician-patient contacts would require separate mini-trials rather than be matters of common proof.¹⁵

12 For example, Nidek's opposition argued the proposed class definitions suffered from overbreadth, because the class definition included persons whose surgeries occurred more than four years before the action commenced, and whose claims would be barred under the absolute statute of limitations of the UCL (Snapp & Associates Ins. Services, Inc. v. Robertson (2002) 96 Cal.App.4th 884, 891) and potentially barred by the discovery by each individual class member of the nonapproved status of the Laser. Moreover, because the proposed class was defined as anyone who had "hyperopic laser surgery," it could encompass those solely treated for hyperopia (the unapproved use) or those whose doctors treated them for myopia with astigmatism (an approved treatment as of April 2000) using the hyperopic functions of the Laser in conjunction with other features, as described by Dr. Ma. Nidek also asserted plaintiffs lacked standing to pursue class claims against anyone other than Nidek and Kawesch, because a plaintiff has standing under the UCL only if he or she suffered injury as a result of the unfair competition (here, the unfair business practices or false advertising) by the named defendants (in plaintiffs' case, Nidek and Kawesch), and Nidek questioned whether plaintiffs had standing to pursue recovery for similar acts by doctors from whom plaintiffs suffered no injury.

13 After noting plaintiffs alleged they were misled because they relied on the "informed consent" provided by Kawesch (which described hyperopic treatment as off-label but not as unapproved), Nidek pointed out neither plaintiff could recall the contents of the conversations they had with Kawesch or his staff that might have clarified what off-label signified. Moreover, there was no evidence the other proposed physician defendants used a similar form, or even that Kawesch's form did not change over time. Conversely, there was affirmative evidence (from Dr. Ma) that other physicians explicitly told prospective patients of the nonapproved status of the Laser. Moreover, Nidek noted the FDA required Nidek to provide physicians with a PIB (Patient Information Book) for the physician to provide to patients considering surgery, and the PIB explicitly disclosed the Laser was not approved for hyperopia. Defendants argued these facts would require mini-trials on the content of each physician/patient oral discussion about the Laser, as well as whether each specific class member received and read the PIB and, if so, what discussions transpired between that patient and physician concerning the information in the PIB. Finally, a mini-trial regarding the materiality of the information would be required, because FDA approval may have been important to some patients while other patients (as apparently occurred in Dr. Ma's practice) may have relied on their physicians' experience and advice that the Laser was superior to other alternatives and/or may have chosen the nonapproved Laser because it was preferable to pricier alternatives.

14 Plaintiffs' class certification motion expressly eschewed recovery of personal injury damages, and instead claimed recovery for (among other things) the entire cost of the surgery (because they did not receive what they had been promised) or, alternatively, the difference between the value of what they had been promised (surgery on an approved Laser) and what they received (surgery on a nonapproved Laser).

15 For example, plaintiffs underwent their procedures in May 2001 but alleged any limitations period was tolled as to them because (1) they believed their subsequent physical difficulties were normal risks of the procedure rather than being caused by the use of an unapproved Laser, and (2) they were assured by Kawesch (during follow-up visits) any problems they were experiencing were normal and expected. Accordingly, for each class member potentially subject to a limitations defense, tolling questions would require mini-trials regarding the nature and onset of postsurgical problems, whether that class member had been told in advance such problems were customary, and/or whether that class member had been told during postsurgery discussions with his or her physician such problems were customary or expected.

The defendants also argued causation issues, damages issues, and even restitutionary issues would require individualized rather than common proof. First, defendants argued plaintiffs' common law claims for fraud and negligence would call for individualized proof of causation and damages.¹⁶ Second, because recent case law had determined violations of the UCL and FMA did not automatically permit the consumer to a refund of all funds parted with, but instead required some evidentiary showing of the difference between the value of the item as represented and the actual value of the item received by the consumer (see Colgan v. Leatherman Tool Group, Inc. (2006) 135 Cal.App.4th 663, 698-700 (Colgan)), defendants asserted the value given to each patient would require an examination of the benefits of each surgery in comparison to the amounts paid, requiring individualized, rather than common, proof. Moreover, because amendments to the UCL imposed a requirement of proof of causation and injury in fact for claims under the UCL, each class member would be required individually to show both causation (reliance on the misrepresentation or concealment) and actual injury from reliance.

16 Common law fraud (plaintiffs' seventh cause of action) requires, at a minimum, proof of causation (e.g. the class member would not have purchased the surgery had he or she known the true facts) and injury, which in an ordinary fraud claim is measured as the difference between the actual value of the service received and the amount parted with in reliance on the fraud. The actual value presumably would vary with the results of each procedure. The common law negligence claim (plaintiffs' 11th cause of action), alleged defendants breached their duty of care to give notice to prospective patients that the Laser was not approved and such breach proximately caused economic and personal injury to class members, again requiring individualized proof of causation and injury.

Nidek additionally noted plaintiffs' claims against it included (1) fraud and negligence claims revolving around Nidek's dealings with the physicians, (2) claims of conspiracy between Nidek and each named and Doe physician, and (3) claims alleging false advertising committed by physicians for which Nidek was allegedly liable under agency principles. Accordingly, Nidek asserted there would be 60 to 70 mini-trials (for the nationwide class) or 17 mini-trials (for the California class) addressing Nidek's dealings with each of the physicians who used the Laser for off-label procedures. These mini-trials would involve numerous subissues, including Nidek's discussions with each physician, and Nidek's variable levels of activities in facilitating (or conversely attempting to prevent) each specific physician's use of the Laser for unapproved procedures. Moreover, as to each physician with whom Nidek dealt, those mini-trials would be further subdivided into patient-specific groups, because each physician-specific mini-trial would require segmenting that doctor's patients into groups based on when the patient was treated.¹⁷

17 Nidek noted some doctors (like Dr. Kawesch) obtained the Laser from Nidek with hyperopic software (based on their participation in clinical trials), although others (like Dr. Ma) obtained unauthorized "chips" Nidek did not immediately discover. Nidek argued any liability it may have had to patients could vary depending on when they were treated because, for example, a patient treated by Ma before Nidek discovered the unauthorized chip (or before Nidek learned Kawesch had been dropped from the clinical study), as well as patients treated by Ma after Nidek installed the blocking software (see fn. 10, ante), could involve different considerations than were applicable to those patients treated when Nidek was aware Ma (as well as Kawesch) had the unauthorized capability to perform hyperopic procedures. Nidek argued similar sub-subgroups would be required for each physician in the national or California classes proposed by plaintiffs' motion to certify.

D. The Ruling Denying Class Certification

The court denied the class certification motion because it concluded the common issues to be tried did not predominate when compared to the issues requiring individual determination, and therefore the common issues were not sufficiently numerous and substantial to make a class action advantageous.¹⁸ The court specifically noted, unlike typical class actions alleging false advertising (which involve a uniform representation received and allegedly relied on by the entire class), the misrepresentations forming the basis for the claims alleged in plaintiffs' SAC were not uniform. Instead, the evidence supported the conclusion each class member received differing representations because each doctor would have communicated (or failed to communicate) with his or her patient in a unique way, both in the doctor's written materials (such as their informed consent forms) and in their oral discussions with each patient in advance of the procedure. The trial court additionally noted the nature of plaintiffs' pleaded claims required individualized factual determinations on such questions as reliance, causation, and the appropriate amount of any damage award to each patient, and therefore any potential common issues presented by the allegations were outweighed by the individual issues that would splinter the class.

18 Because of its conclusion on the commonality issue, the court specifically found it was unnecessary to address the other significant impediments to class certification, including ascertainability, manageability, typicality, or the propriety of a nationwide class.

IV

THE TRIAL COURT DID NOT ABUSE ITS DISCRETION BY DENYING THE ORIGINAL CERTIFICATION MOTION

The trial court, after examining the pleaded claims on which plaintiffs' proposed class action would proceed, denied certification because it concluded the common issues to be tried on those claims did not predominate over the issues requiring individual determination to establish each class members' right to recover on the pleaded claims. We must evaluate whether the trial court abused its discretion in concluding, considering plaintiffs' proposed class and the claims plaintiffs sought to prosecute on behalf of the class,¹⁹ the noncommon questions made it either inefficient or impractical to permit the action to proceed on behalf of the class.

19 Plaintiffs subsequently moved for reconsideration under section 1008, arguing the court should certify a different class under different criteria and allegations. Although we separately discuss below plaintiffs' claim that the court erred by denying their motion for reconsideration, our evaluation of whether the court abused its discretion in its ruling denying the original certification motion is appropriately limited to the factual and legal landscape within which the trial court's discretionary ruling was made.

We conclude the trial court's ruling was not an abuse of discretion and was supported by substantial evidence. When evaluating whether to permit an action to proceed as a class action under the community of interest element, it is not sufficient that there are some questions of law or fact common to the proposed class. Instead, the court must also evaluate predominance and decide whether " 'the issues which may be jointly tried, when compared with those requiring separate adjudication, [are] sufficiently numerous and substantial to make the class action advantageous to the judicial process and to the litigants.' " (Washington Mutual Bank v. Superior Court (2001) 24 Cal.4th 906, 913-914.) A court may properly deny certification where there are diverse factual issues to be resolved even though there may also be many common questions of law of law or fact. (Basurco v. 21st Century Ins. Co. (2003) 108 Cal.App.4th 110, 118.)

Substantial evidence supports the conclusion that common questions did not sufficiently predominate over the noncommon questions to make prosecution of the pleaded claims on behalf of the defined class advantageous to the judicial process or to the litigants. The bulk of plaintiffs' UCL/FMAA claims against the named and Doe physicians,²⁰ as well as the CLRA and common law claims for intentional misrepresentation by concealment, conspiracy and negligence asserted against all defendants, turned on the assertion that the physicians misrepresented the Lasers as appropriate or approved for hyperopic procedures, or intentionally concealed (or negligently failed to disclose) that the Lasers were not approved for such treatments, and/or conspired to engage in such conduct. (See section III.A, ante.)

20 After Nidek's motion for summary adjudication was granted, the UCL/FMAA claims were only directed at the named and Doe physician defendants.

Even if the sole focus of plaintiffs' complaint had been against the physician-defendants (in California and throughout the country), and we were to disregard the additional factual complexities presented by plaintiffs' attempt to affix direct or vicarious liability on Nidek, there is substantial evidence the individualized questions would have predominated over the common questions. The trial court had substantial evidence (from Dr. Ma's evidence submitted in connection with his opposition to the class certification motion)²¹ to support a conclusion that plaintiffs' misrepresentation/concealment/nondisclosure claims would have required a mini-trial to assess each permutation of the representations made to each class member by 60 to 70 doctors or their staff (if the national class was certified) or at least 17 doctors or their staff (if only the proposed California class was certified), and required an examination of the informed consent forms signed by the patient, and/or each patient's discussion with his or her doctor or staff, and/or whether the PIB book had been given to some patients by some physicians, to determine which patient received what information about the status of the Laser as well as whether the particular patient understood the information given to that patient.²² This issue alone would have splintered the defined class into patient-specific mini-trials of one subissue (the "misleading disclosures" issue) for a service rendered by between 17 to 70 physicians. (See, e.g., Caro v. Procter & Gamble Co. (1993) 18 Cal.App.4th 644, 668-669 [trial court's denial of certification for lack of predominance not abuse of discretion where claim may require particularized evaluation of nature of representations and extent of reliance by class members on representations]).

21 On appeal, plaintiffs argue the trial court improperly relied on Dr. Ma's evidence to conclude some physicians may have revealed the Laser's status to patients. They assert that because they objected to the evidence below and the court erroneously ignored that objection, the trial court had no competent evidence from which to conclude mini-trials on the representation/concealment/nondisclosure issue would have splintered the class action. However, plaintiffs neither identify where they interposed below any evidentiary objection to the admissibility of Ma's evidence, nor explain on appeal what evidentiary error was made in admitting and considering such evidence, and we therefore deem any objection to the competence of Ma's evidence waived.

22 For this reason, plaintiffs' citations to Massachusetts Mutual Life Ins. Co. v. Superior Court, supra, 97 Cal.App.4th 1282 and Vasquez v. Superior Court, supra, 4 Cal.3d 800 are inapposite. In those cases, the courts concluded individualized determinations of reliance would be unnecessary where either the class received a standardized misrepresentation (as in Vasquez, at pp. 811-812) or the identical nondisclosures deprived class members of the same material information (as in Massachusetts Mutual, at pp. 1292-1295). Here, in contrast, the fact there was evidence that class members received differing information (from either discussions with their physicians or from the PIB booklet) makes plaintiffs' reliance on Vasquez and Massachusetts Mutual inapposite.

The requisite patient specific mini-trials would be further complicated by the fact that the physicians making (and the patients receiving) the representations spanned an approximately seven-year period (cf., Quacchia, supra, 122 Cal.App.4th at pp. 1449-1454 [CLRA and UCL claims based on seat buckle installed in 17 different cars over 10-year period; trial court did not abuse discretion in concluding predominance for the defined class was not shown because evaluation of whether or not buckles were defective would require particularized examination of each distinct configuration for the product]), which would additionally splinter the class action into patient-specific mini-mini-trials because statute of limitations and tolling issues for many (if not most) of the class members (see fn. 15, ante) would require individualized resolution. (See, e.g., Block v. Major League Baseball (1998) 65 Cal.App.4th 538, 544-546 [trial court's denial of certification not abuse of discretion where defenses required particularized evaluations of each class member's claim].) Accordingly, and contrary to plaintiffs' arguments on appeal,²³ there was substantial evidence from which the trial court could conclude plaintiffs' SAC did not plead claims as against the physician defendants involving issues common to the class as a whole that predominated over the issues specific to each class member.²⁴

23 On appeal, plaintiffs assert any variation in the communications between class-member patients and the named and Doe physicians is irrelevant because the physicians were required but failed to provide their patients with statutorily prescribed informed consent forms, and this omission provided independent support for their UCL, FMA, CLRA and common law claims. However, this factual basis was not pleaded in the SAC, and plaintiffs did not argue (in connection either with their class certification motion or as part of their class definition) this common omission provided the requisite commonality to support class certification. Instead, the first hint of this theory appears to have surfaced when plaintiffs moved for reconsideration of the order denying certification and, even then, it was not mentioned until plaintiffs filed their reply brief to defendants' opposition to the motion for reconsideration. Because plaintiffs' arguments on appeal raise factual contentions not raised below in connection with the ruling they appeal, we decline to consider those arguments in assessing whether the trial court abused its discretion when it ruled on the original certification motion.

24 Although the court expressly found it unnecessary to evaluate the "typicality" requirement, plaintiffs' efforts to pursue a class action against Ma and Kownacki, as well as against between 17 to 70 Doe physicians, presented an additional impediment to certification. As explained by this court in Hart v. Alameda County, supra, 76 Cal.App.4th at pp. 775-776, "[u]nder California's class action statute, when a class action is brought against multiple defendants, the 'action may only be maintained against defendants as to whom the class representative has a cause of action. Without such a personal cause of action, the prerequisite that the claims of the representative party be typical of the class cannot be met. If the plaintiff class representative only has a personal cause of action against one defendant and never had any claim of any kind against the remaining defendants, his claim is not typical of the class . . . . Th[is] . . . requirement is . . . not fulfilled merely because the plaintiffs allege that they suffered injuries similar to those of other parties at the hands of other defendants.' (Baltimore Football Club, Inc. v. Superior Court (1985) 171 Cal.App.3d 352, 359 [215 Cal.Rptr. 323], fn. omitted; accord, Simons v. Horowitz (1984) 151 Cal.App.3d 834, 845 [199 Cal.Rptr. 134] ['A plaintiff cannot use the procedure of a class action to establish standing to sue a class or group of defendants unless the plaintiff has actually been injured by each of the defendants in the class.' (Italics deleted.) ].)" Although plaintiffs argue their complaint fell within the exception to this rule, which applies "where the plaintiff alleges the defendants acted under a conspiracy or the defendants are jointly responsible for the plaintiffs' injuries," plaintiffs made no effort to introduce any evidence suggesting any of the proposed Doe defendant physicians conspired with each other as would render them vicariously liable for the acts of each other physician. Because the burden is on the plaintiffs to establish that certification is warranted, and a trial court is entitled to consider "the totality of the evidence in making [the] determination" of whether a "plaintiff has presented substantial evidence of the class action requisites" (Quacchia, supra, 122 Cal.App.4th at p. 1448), the proposed multiplicity of potential defendants posed standing problems in addition to requiring individualized trials on the nature of the alleged representations.

Moreover, there was evidence from which the trial court could have concluded that, even after splintering the class into patient specific mini-trials addressing the misrepresentation questions and statute of limitations questions, an additional overlay of class subdivisions would be required when plaintiffs' claims against Nidek are factored into the matrix. Each subgroup involved in the particular mini-trial of whether a doctor's particularized disclosures were or were not adequate to inform the patient of the Laser's status would itself be further subdivided into sub-subgroups along a distinct axis of questions posed by plaintiffs' claim that Nidek was directly or vicariously liable for a physician's off-label use of the Laser. For example, plaintiffs alleged Nidek had vicarious liability for the physician's inadequate disclosures because Nidek conspired with the particular physician to equip the Laser with unapproved software and/or to maintain the Laser for use in unapproved procedures, thereby requiring individualized mini-trials on the communications between each of the 17 to 70 physicians and Nidek to determine whether the alleged conspiracy existed between Nidek and the particular physician. Additionally, to the extent plaintiffs alleged Nidek was directly liable for a specific class member's injury because Nidek directly supplied the unapproved software to each physician, enabling that physician to perform the hyperopic procedures, or because Nidek was dilatory either in discovering or taking steps to block software obtained by physicians from third parties, mini-trials on Nidek's dealings with each physician would be necessary. We cannot conclude it was an abuse of discretion for the trial court to conclude such particularized evaluations of each class member's claim militated against a finding that issues common to the class as a whole predominated over individualized issues among countless subsets of class members. (See Caro v. Procter & Gamble Co., supra, 18 Cal.App.4th 644.)

Finally, the recoverable damages or restitution created an additional overlay of issues that would necessitate individualized evidentiary determinations, thereby additionally splintering the class, because of the multi-faceted claims that plaintiffs' certification motion sought to pursue. For example, plaintiffs' common law fraud claim, where damages are ordinarily measured by the difference between the value parted with and the actual value received (see generally Persson v. Smart Inventions, Inc. (2005) 125 Cal.App.4th 1141, 1165), would require an analysis of what each patient received, thereby requiring an examination of the results of each surgery.

Moreover, because there was evidence some patients underwent "mixed" procedures, in which the approved uses of the Laser (for myopic corrections) were accompanied (either concurrently or in follow-up corrective procedures) by unapproved uses of the Laser,²⁵ it appears the recoverable damages for many patients would require an additional segregation between the respective values attributable to each aspect of the procedure. Similar damages issues would arise under the common law negligence claim, because the alleged breach (pleaded as the breach of the duty of care to give notice to patients that the Laser was not approved for hyperopic corrections) would require an accompanying showing of proximately caused economic injury to class members (presumably from lost income from a poor result) and necessitate "malpractice" mini-trials for each class member.²⁶

25 Ma testified that approximately two-thirds of the hyperopic procedures he performed were "enhancements," for which he charged nothing, and many of the "virgin" eye treatments in which he used the hyperopic functions were mixed procedures in which the eyes were also being treated for myopia or myopia with astigmatism.

26 Although plaintiffs attempted below to delimit the certification to pursuit only as to "non-personal injury damages" suffered by the class, plaintiffs' concurrent effort to claim economic damages suffered by the class under such causes of action as their fraud, negligence, medical malpractice and negligence per se causes of action contained no explication of how such damages would be identified and quantified without inquiring into the results of the procedures.

Additionally, it appears plaintiffs' CLRA claim would also require a comparison of the amounts paid for each procedure and the value received by each patient, rather than (as plaintiffs assert on appeal) restitution of the full amount paid for the procedure without regard to the benefits conferred (e.g. the result of the procedure) on the patient. Although restitution is the remedy provided under the UCL and FMAA, the remedy provided by the CLRA consists of the actual damages suffered by the consumer from the falsely advertised product. (Colgan, supra, 135 Cal.App.4th at p. 695.) Plaintiffs made no effort below to articulate how a class member's actual damage under the CLRA would be measured without evaluating of the results of the particular procedure, and the court concluded mini-trials to evaluate the results of each particular procedure would be necessary and thereby presented an additional impediment to class certification.²⁷ Thus, even ignoring whether plaintiffs' claims for restitution under the UCL and FMAA would also raise potential complexities that could defeat the benefits of class treatment of plaintiffs' claims,²⁸ the trial court had substantial evidence from which to conclude the damages issues raised by plaintiffs' non-UCL/FMAA causes of action created such myriad variations within the defined class that the requisite substantial benefit to the courts and the litigants necessary to certify plaintiffs' proposed class action (Linder, supra, 23 Cal.4th at p. 435) was absent here.

27 Plaintiffs, in a theory newly minted for this appeal, assert the recoverable CLRA damages would be the entire amount paid by the patient. Even ignoring the mini-trials required to determine what portion of a particular patient's fee might be attributable to the unapproved application of the Laser (see, e.g., fn. 25, ante), plaintiffs' new theory is (1) use of the Laser was unlawful under FDA regulations, (2) the value of any service rendered in violation of law is $0 (by analogy to cases holding unlicensed contractors and brokers are not entitled to collect for their services), and (3) therefore, a class member's damages consist of the difference between the amount paid and $0. We have significant doubts that the contractors and brokers cases are sufficiently analogous to the present case to support plaintiffs' argument, because those cases involved express statutory proscriptions (see Bus. & Prof. Code, § 7031, subd. (a) [unlicensed contractor cannot maintain action to collect on contract for which license was required]; Bus. & Prof. Code, § 10136 [brokers cannot maintain action to recover commission unless licensed]), and plaintiffs cite no similar express statutory ban that would apply to physicians under circumstances analogous to those presented here. More importantly, plaintiffs did not raise this argument below, and we therefore decline to hold the trial court abused its discretion for not divining and considering this argument when it concluded common issues did not predominate over individual issues. (Cf. Ernst v. Searle (1933) 218 Cal. 233, 240-241 ['The rule is well settled that the theory upon which a case is tried must be adhered to on appeal. A party is not permitted to change his position and adopt a new and different theory on appeal. To permit him to do so would not only be unfair to the trial court, but manifestly unjust to the opposing litigant"].)

28 The trial court below, relying on Colgan, supra, 135 Cal.App.4th 663, also concluded the restitutionary relief under the pleaded UCL/FMAA claims was not amenable to class treatment. The trial court concluded, under Colgan, restitution would not necessarily be measured by the entire amount paid by a class member for his or her procedure, but could instead be limited to the "added value" of having the procedure conducted using an FDA-approved device rather than the Laser, and indicated this potential complexity would involve individualized proofs of the degree to which each individual patient expected he or she was receiving treatment on an FDA-approved device, as well as the degree to which (in a mixed procedure) the Laser was used for the nonapproved purpose. Colgan did evaluate a class action that pleaded UCL/FMAA claims on behalf of consumers induced to buy a product falsely advertised as having certain attributes or qualities, and recognized that restitutionary relief under those statutes must be limited to restoring to the consumer " 'those measurable amounts which are wrongfully taken by means of an unfair business practice,' " which Colgan suggested could be measured as the amount "necessary to make injured consumers whole." (Id. at pp. 693-700.) Plaintiffs (as well as the Attorney General in his amicus brief) assert the restitutionary award as a matter of law would be the entire amount paid for the hyperopic procedure, and argue the trial court erred in interpreting Colgan to permit a court to measure a restitution award by comparing the value of the service as represented (treatment using an approved device) and the value of the service actually provided (treatment using the Laser) and only restoring to the consumer any "added value" he or she was deprived of and obtained by the physicians by virtue of the false representation. We need not resolve this issue because, even if the trial court either misconstrued Colgan's restitutionary approach or erroneously concluded such approach was applicable on these facts, the other numerous grounds relied on by the trial court to deny certification amply support the order, and therefore any alleged erroneous reliance on Colgan was harmless.

We conclude, based on the causes of action asserted, the proposed class definition, and the arguments and evidentiary showing presented in connection with the original certification motion, the trial court's denial of the original certification motion was not an abuse of discretion.

V

THE ARGUMENTS TENDERED By PLAINTIFFS IN CONNECTION WITH THEIR MOTION FOR RECONSIDERATION DO NOT COMPEL REVERSAL OF THE ORDER DENYING THEIR CERTIFICATION MOTION

Background

After the trial court denied plaintiffs' certification motion, plaintiffs filed a motion, styled as a motion for reconsideration under section 1008, subdivision (a), alleging there was new law or facts justifying reconsideration of the motion for certification. Plaintiffs argued there was newlaw (a new federal case published less than two weeks earlier, Dukes v. Wal-Mart, Inc. (9th Cir., 2007) 474 F.3d 1214, opinion withdrawn and superseded on denial of rehearing by Dukes v. Wal-Mart, Inc. (9th Cir., 2007) 509 F.3d 1168), that required a different analysis of the certification motion. Plaintiffs also argued new facts existed because they tendered a revised class description. First, plaintiffs argued the newly proposed class was limited to two groups (patients of Kawesch and patients of other California physicians), thereby eliminating the complexities presented by the previously proposed nationwide class. Second, plaintiffs argued the newly proposed class involved a newly revised class description that changed the description of the class from "[a]ll persons who had hyperopic laser surgery performed using a [Laser] who were not enrolled in a clinical trial" to instead "[a]ll persons who had their initial hyperopic laser surgery performed . . . using the [Laser] . . . who did not execute an informed consent form that stated the Laser was not FDA-approved." Plaintiffs asserted these new definitions provided new facts warranting reconsideration because the new description eliminated any need for individual determinations as to the nature of each patient's discussions or understandings concerning the FDA status of the Laser. Finally, plaintiffs argued new facts existed because the court's order on Nidek's summary adjudication motion simplified the restitution issues by limiting any potential restitution order to those physicians who directly received funds from the class members. Defendants opposed the motion, arguing (1) the motion was procedurally deficient because plaintiffs had not produced any new law or facts,²⁹ and (2) the revised class definitions did not alter the analysis previously adopted by the court because the individualized issues still would predominate over the common issues. Defendants also argued reconsideration was unwarranted because, even under the newly defined class, the other questions (e.g. ascertainability, typicality and standing) remained obstacles to certification.

29 Defendants argued Dukes was not new law but instead merely restated existing law, and argued the revised class definitions did not constitute new facts but instead reflected merely a change in litigation tactics.

In plaintiffs' reply to defendants' opposition to the motion for reconsideration, plaintiffs raised--for the first time--an argument that appears to have evolved into a centerpiece of their argument on appeal: each patient's discussions or understandings concerning the FDA status of the Laser are irrelevant because no member of the proposed class had signed the consent forms required under federal and state law for experimental subjects (21 C.F.R. § 50.20 et seq.; Health & Saf. Code, § 24173), and therefore there was a sufficient community of interest to permit the class action to be certified.³⁰ As articulated in their reply brief filed below, plaintiffs asserted the use of a nonapproved Laser transmuted each patient from a person seeking therapeutic treatment into an unwitting subject of an experiment, and this triggered the requirements of the detailed consent forms mandated by 21 Code of Federal Regulations part 50.20 et seq. and Health and Safety Code section 24173.

30 Defendants objected to plaintiffs' effort to interject this new theory, arguing, among other things, (1) a new theory does not constitute new facts within the meaning of section 1008, and (2) plaintiffs' new theory was legally unsound.

The court denied the motion for reconsideration, concluding plaintiffs had failed to make the requisite showing of new facts or law and, even if these new theories were considered, the noncommon issues still predominated over the common issues.

Discussion

As a preliminary matter, we have substantial doubt that any of the arguments first raised in plaintiffs' motion for reconsideration are properly before this court. First, although plaintiffs purported to appeal from the order denying reconsideration, that order is not appealable.³¹ (Reese v. Wal-Mart Stores, Inc. (1999) 73 Cal.App.4th 1225, 1242.) Second, although plaintiffs' appellate brief contains interspersed references to their failure to comply with experimental subjects consent form theory as demonstrating the trial court abused its discretion when it concluded individualized determinations on patient's discussions would be required, plaintiffs' opening brief in this appeal argues for and seeks reversal of the order denying certification of their original nationwide and California classes. Plaintiffs' failure to proffer any argument asserting the order denying certification of the newly defined and limited class should be reversed permits us to deem waived or abandoned any claim of error as to rulings on those latter classes. (Graham v. Lenzi (1995) 37 Cal.App.4th 248, 259, fn. 10.)

31 Even if the reconsideration order was properly before us on appeal, plaintiffs offered no argument below (or articulate on appeal) how their new theory (the "experimental subjects consent form" theory) constitutes new facts, nor offered any explanation why this new fact/theory was not presented as part of their original motion, both of which are predicates to a proper motion for reconsideration. (See Morris v. AGFA Corp. (2006) 144 Cal.App.4th 1452, 1460.) We also agree with the trial court's conclusion that Dukes v. Wal-Mart, Inc., supra, 509 F.3d 1168 did not create new law within the contemplation of section 1008, but instead merely applied existing criteria to conclude the trial court did not abuse its discretion when it ruled on the certification motion in Dukes. On appeal, plaintiffs offer no persuasive explanation of why Dukes represented such a significant change in the legal landscape as to warrant reconsideration under section 1008.

On appeal, plaintiffs instead appear to assert, because no patient signed the experimental subjects consent form, the court abused its discretion when it relied on other purported disclosures to patients about the nonapproved status of the Laser (in either oral discussions or other written disclosures) to find noncommon issues predominated. Although plaintiffs assert on appeal that the experimental subjects consent form was a common omission expressly stated in the SAC as the basis for recovery and made part of the class definition, our independent search of plaintiffs' SAC, as well as our review of plaintiffs' original certification motion and accompanying class definition, reveals no express reference to the failure to comply with experimental subjects consent form theory as the alleged common fact upon which plaintiffs' UCL/FAA, CLRA, or common law claims were predicated. Indeed, if this limited claim had been the core common issue that assertedly justified class certification, plaintiffs' complete silence on this theory in their original certification motion constituted a failure to carry their burden to establish the existence of a well-defined community of interest (Linder, supra, 23 Cal.4th at p. 435) sufficient to uphold the trial court's order denying certification.

Finally, even assuming plaintiffs' late-proffered theory created one legally tenable alternative basis for recovery,³² plaintiffs made no effort to limit the requested class certification to a cause of action resting solely on the failure to have particularized consent forms signed by the patients. Instead, plaintiffs sought certification of the class for all 11 of plaintiffs' pleaded causes of action, which expressly included (1) causes of action under the UCLA/FMAA and CLRA based on express representations and/or intentional omissions to patients, (2) a common law claim for fraud based on the failure to reveal the Laser was not approved for hyperopic procedures, (3) a common law claim for negligence alleging a duty of care was owed to give notice to prospective patients that the Laser was not approved and such duty was breached, and (4) a claim alleging all defendants conspired to misrepresent the safety of the Laser and withhold from the public the fact that use of the Laser for hyperopic procedures was unlawful. Thus, even assuming plaintiffs had properly pursued leave to amend their complaint to expressly include a claim arising out of the failure of the physicians' informed consent form to comply with statutory obligations under the experimental subjects consent form statutes,³³ and assuming plaintiffs had been able to carry their burden of showing sufficient commonality would have existed on that new cause of action as to warrant certification as to that claim, the same noncommon issues identified by the trial court would nevertheless have remained as to all other claims on which certification was requested. Because we have already concluded the trial court did not abuse its discretion in finding the noncommon issues on all other claims predominated over the common issues for those claims, we cannot conclude it was an abuse of discretion to deny certification even if plaintiffs' complaint had expressly or (adopting a very liberal construction) inferentially included claims premised solely on the physician's alleged obligation to obtain the consent forms required by Health and Safety Code section 24173 and 21 Code of Federal Regulations part 50.20 et seq.³⁴

32 The defendants dispute that Health and Safety Code section 24173 or the corresponding federal requirements are applicable here. Under California's "Protection of Human Subjects in Medical Experimentation Act" (Health & Saf. Code, § 24170 et seq.), the required disclosures and consent apply when a device is used in the "research of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject." (Health & Saf. Code, § 24174, subd. (a).) As explained by the court in Trantafello v. Medical Center of Tarzana (1986) 182 Cal.App.3d 315, 320 to 321, footnote 2, the detailed informed consent requirements "deal with experiments on human subjects in the course of pure research. It applies 'in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of such subject or otherwise directly benefiting such subject.' [Quoting Health & Saf. Code, § 24174, subd. (a).] Here [the physician] used the acrylic implant not in the course of a medical research program but in a course of therapeutic treatment for plaintiff. His duty to inform plaintiff of the alleged innovative nature of the treatment did not arise from the Health and Safety Code provisions but from the general rules [for informed consent.]." (Italics added.) Although plaintiffs rely on Daum v. SpineCare Medical Group, Inc. (1997) 52 Cal.App.4th 1285 as establishing a duty to use the statutorily prescribed forms, the physician in Daum used the device as "part of an FDA-approved clinical investigation of the [device] conducted by SpineCare" (id. at p. 1293), and the court concluded the statutory informed consent form was required because the patient was part of the research project. (Id. at pp. 1306-1311.) There was no evidence any of the class members, much less all of the proposed class members, were treated by their physicians for research purposes rather than to obtain therapeutic benefits for the patient.

33 Although plaintiffs' reply brief on the motion for reconsideration contained an oblique reference to a possible need to amend their complaint, the record contains neither an application by plaintiffs to file an amended complaint asserting a separate claim arising under their newly minted experimental subjects consent form theory, nor any copy of the proposed pleading asserting such a claim, as required under California law. (See Cal. Rules of Court, rule 3.1324(a).) Although plaintiffs suggest (in their reply brief on appeal) the trial court should have granted leave to amend the pleadings to allow the new theory to be explored as an alternative basis for certification, plaintiffs' failure to seek leave to amend or to attach a proposed new pleading alone is sufficient for this court to conclude the trial court did not abuse its discretion in declining to consider plaintiffs' proposed new theory. (See generally 5 Witkin Cal. Procedure (5th ed. 2008) Pleading, § 1200, p. 632.) Because the trial court was not required sua sponte to divine whether plaintiffs' new theory would be a viable claim or whether a class action pursuing such claim was appropriate for certification, we reject plaintiffs' claim that it was an abuse of discretion to deny certification based on this new theory.

34 At oral argument before this court, plaintiffs appeared to tender yet another theory, different from the argument raised at trial and from the argument raised in their appellate briefs, to assert the trial court erred in denying their original class certification motion. Plaintiffs at oral argument asserted (1) they sought only to certify a class for their restitutionary claims under the UCL/FMAA, and (2) their theory was that (as a matter of law) a class member could not give informed consent for a procedure a physician could not lawfully perform. Under this newest version of their class certification motion, plaintiffs assert (1) because they did not seek certification of the class to pursue either nonpersonal injury compensatory damages or punitive damages on behalf of class members, any issues of individualized harm did not defeat commonality because individualized harm was irrelevant to their class claims; and (2) because a class member could not give consent to an illegal procedure, any individualized discussions between each doctor and patient did not defeat commonality because consent was irrelevant to their class claims. However, plaintiffs' latest iteration ignores that, in their original class certification motion, they requested an order "certifying a nationwide class as to all claims for [nonpersonal] injury damages alleged" (not just the UCL/FMAA claims), and specifically expanded on that by explaining "[t]hese claims include economic damages" (not just restitution) "and those punitive damages associated with Defendants' fraudulent conduct." Indeed, when plaintiffs (as part of their class certification motion) listed the "common questions" that made this action amenable to class treatment, they included "whether [defendants] violated the [CLRA]," which necessarily implicated questions of damages rather than restitution. (See Colgan, supra, 135 Cal.App.4th at p. 695.) Because plaintiffs' newly minted theory was not raised below, and contradicts the position they took below, we cannot hold the trial court abused its discretion for not divining and considering this argument when it concluded common issues did not predominate over individual issues. (Cf. Ernst v. Searle, supra, 218 Cal. At p. 240.) Moreover, we have substantial doubts whether, even under this revisionist construction of plaintiffs' certification motion, the individualized discussions between each doctor and patient would be irrelevant, because disclosures about the unapproved status of the Laser could still be relevant to statutes of limitations issues (as to class members treated more than four years before the complaint) and potentially relevant to remedy questions insofar as a consumer's knowing agreement to (and benefit from) using an illegal device to accomplish the procedure might present in pari delicto or unclean hands considerations. (See generally Cortez v. Purolator Air Filtration Products Co. (2000) 23 Cal.4th 163, 179-181.) However, because this iteration of plaintiffs' argument did not surface until oral argument on appeal, it is untimely and "given its untimeliness, we consider the argument no further." (Estate of McDaniel (2008) 161 Cal.App.4th 458, 463.)

VI

CONCLUSION

Our conclusion that the trial court did not abuse its discretion in ruling on plaintiffs' class certification motion should not be construed as expressing any opinion either as to the merits of plaintiffs' individual claims against Kawesch or Nidek or as to the tenability of class treatment for a complaint directed at a more limited group of defendants (see generally Baltimore Football Club, Inc. v. Superior Court, supra, 171 Cal.App.3d at pp. 358-359) and/or containing more limited types of claims. Instead, we hold only that, based on the multiplicity of the causes of action asserted, the proposed class definitions and proposed defendants, and the arguments and evidentiary showing presented in connection with the original certification motion, the trial court's denial of the original certification motion was not an abuse of discretion.

DISPOSITION

The purported appeal of the order granting summary adjudication is dismissed. The order denying certification of the class is affirmed. Defendants shall recover costs on appeal.

WE CONCUR: McCONNELL, P. J., McINTYRE, J.

"The original excimer laser was approved by the FDA in October of 1995 for use in the United States. When the FDA approves a device or medication, they provide labeling guidelines. These are based upon how the medication or device was used during the FDA trials. Physicians are allowed to use any FDA approved medication or device in a manner different from the labeling guidelines if they determine it would be in their patients best interest. These are called 'off-label' uses. All of the Lasers that we use in this practice are FDA approved. Based upon your prescription and the type of laser that we use for your treatment, you may be undergoing an 'off-label' treatment. [¶] This form outlines various off-label uses of the excimer laser, which we use in our practice: [¶] . . . [¶]

"Hyperopia ('Farsightedness') . . . can now be treated with the excimer laser. Hyperopic Lasik [is] considered Off-label use[] of the excimer laser. [¶] . . . [¶]

"I understand that I may be undergoing one or more of the off-label uses of the excimer laser indicated above. I have discussed with Dr. Kawesch/Dr. Kownacki[,] and/or their staff, the risks, benefits and alternatives of having this off-label treatment. I understand these risks, benefits, and alternatives and have had all of my questions answered and desire to proceed."

The defendants also asserted the proposed class action triggered both typicality problems and ascertainability issues. Potential typicality issues were presented because, defendants argued, plaintiffs had no claim against physicians who did not treat them, and therefore typicality problems were presented by plaintiffs' proposed class definition. (See Hart v. County of Alameda (1999) 76 Cal.App.4th 766, 775-776.) Additionally, defendants asserted ascertainability issues were present because the burden was on plaintiffs to show the class was ascertainable (Global Minerals & Metals Corp. v. Superior Court (2003) 113 Cal.App.4th 836, 849), as well as manageable, but plaintiffs' class certification motion proposed no method for how they would identify potential class members, particularly when the most obvious source (the physicians' records) would necessitate invasion of the physician-patient privilege.